FDA.reportPublic FDA data

Orthofuser

Primary DI
10803622130790
Brand
Orthofuser
Company
LIVANOVA USA, INC.
Model
Orthofuser
Published
2016-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
CACAPPARATUS, AUTOTRANSFUSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CACApparatus, AutotransfusionAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K912019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K912019000ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEMGish Biomedical, Inc.1991-10-08CAC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10803622130790PackageGS112In Commercial Distribution
00803622130793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080362213079010803622130790
00803622130793008036221307938036221307930803622130793

GMDN Terms#

Term, Definition table
TermDefinition
Blood-processing autotransfusion system containerA simple blood collection container used for the collection of autologous blood from a patient undergoing major surgery. The blood is then cleansed in a line-powered (AC-powered) blood-processing autotransfusion system (commonly known as a cell saver) before the red cells are reinfused into the patient, or stored for later use. It is made of disposable plastic materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080914995
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00803622164774Perfusion PackPerfusion Pack2026-10-06
00803622164781Perfusion PackPerfusion Pack2026-10-06
00803622164798Perfusion PackPerfusion Pack2026-10-06
00803622164866Perfusion PackPerfusion Pack2026-10-06
00803622164873Perfusion PackPerfusion Pack2026-10-06
00803622164880Perfusion PackPerfusion Pack2026-10-06
00803622164897Perfusion PackPerfusion Pack2026-10-06
00803622164903Perfusion PackPerfusion Pack2026-10-06
00803622164736Perfusion PackPerfusion Pack2026-09-29
00803622164743Perfusion PackPerfusion Pack2026-09-29
00803622164859Perfusion PackPerfusion Pack2026-09-29
00803622164651Perfusion PackPerfusion Pack2026-09-28
00803622164675Perfusion PackPerfusion Pack2026-09-28
00803622164682Perfusion PackPerfusion Pack2026-09-28
00803622164705Perfusion PackPerfusion Pack2026-09-28
00803622164712Perfusion PackPerfusion Pack2026-09-28
00803622164729Perfusion PackPerfusion Pack2026-09-28
00803622164767Perfusion PackPerfusion Pack2026-09-28
00803622164378Perfusion PackPerfusion Pack2026-09-22
00803622164477Perfusion PackPerfusion Pack2026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704911810PLEUR-EVACTELEFLEX INCORPORATEDCAC2026-07-22
14026704937230PLEUR-EVACTELEFLEX INCORPORATEDCAC2026-05-08
14026704937308PLEUR-EVACTELEFLEX INCORPORATEDCAC2026-05-08
14026704937315PLEUR-EVACTELEFLEX INCORPORATEDCAC2026-05-08
14026704912206PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-17
14026704912213PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-17
14026704911797PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-04
14026704911803PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-09-04
14026704911865PLEUR-EVACTELEFLEX INCORPORATEDCAC2025-04-29
08033178113700XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113717XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113724XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113731XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113748XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113755XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113762XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113922XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113939XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113946XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113953XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113960XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113977XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113984XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178113991XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114004XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114011XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114028XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114035XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114042XTRASORIN GROUP ITALIA SRLCAC2024-12-20
08033178114059XTRASORIN GROUP ITALIA SRLCAC2024-12-20